The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return. if any further relevant information is received, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a sensation small oval med stiff snare was used during an unknown procedure on (b)(6) 2018.According to the complainant, during the procedure, when the snare was slowly extended, the snare came flying out and went all the way through underneath the mucosa/polyp and created a hematoma.The snare "burrowed" all the way underneath the polyp/mucosa.Reportedly, the snare came out suddenly/unexpectedly and too far and fast and was embedded in the patient's tissue.It was unknown if any treatment or intervention was done to treat the hematoma.The procedure was completed using a different device.The condition of the patient following the procedure was reported to be unknown.Should additional relevant details become available a supplemental report will be submitted.
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